Zovirax 5% w/w Cream

The Summary of Product Characteristics (SPC or SmPC) is a specific document, the wording of which has been agreed with the regulatory authority as part of the medicine approval process. It is required before any medicine is allowed on the market in Europe. It is designed to assist doctors and pharmacists in prescribing and supplying the product.

Updated on 7 August 2007 PIL

Reasons for updating

Updated on 14 June 2007 SmPC

Reasons for updating

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

5.3 Preclinical Safety Data

There is no information on the effect of aciclovir oral formulations or i.v. for infusion on human female fertility. In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.

NON-CLINICAL INFORMATION

Mutagenicity

The results of a wide range of mutagenicity tests in vitro and in vivo indicate that acyclovir does notis unlikely to pose a genetic risk to man.

Carcinogenicity

Aciclovir was not found to be carcinogenic in long-term studies in the rat and the mouse.

Fertility

Largely reversible adverse effects on spermatogenesis in association with overall toxicity in rats and dogs have been reported only at systemic doses of aciclovir greatly in excess of those employed therapeutically. Two-generation studies in mice did not reveal any effect of (orally administered) aciclovir on fertility.

6.1 List of Excipients

Cetostearyl alcohol

Liquid paraffin

Poloxamer 407

Propylene glycol

Purified water

Sodium laurilsulfate

White soft paraffin

Dimeticone 20

Glycerol Monostearate / Macrogol Stearate (Arlacel 165)

Updated on 19 October 2006 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2 Posology and Method of Administration

Zovirax Cream should be applied five times daily at approximately four hourly intervals omitting the night time application.

Zovirax Cream should be applied to the lesions or impending lesions as soon as possible preferably during the earliest stages (prodrome or erythema). Treatment can also be started during the later (papule or blister) stages.

Treatment should be continued for at least four days for herpes labialis and for five days for genital herpes. If healing has not occurred, treatment may be continued for up to ten days.

Updated on 1 September 2006 SmPC

Reasons for updating

Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 4 August 2005 PIL

Reasons for updating

Improved electronic presentation

Updated on 17 August 2004 PIL

Reasons for updating

New PIL for medicines.ie

Updated on 7 July 2003 SmPC

Reasons for updating

New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)